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BioWorld - Sunday, August 14, 2022

IDE

Home » Topics » Regulatory » IDE
  • Man mri prostate
    Aug. 9, 2022
    By Annette Boyle

    FDA advances AI-enhanced tech for prostate diagnosis and treatment

    Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
  • Cardiovascular
    Nov. 18, 2021
    By Catherine Longworth

    Cardialen wins FDA IDE approval for low-energy pulse therapy

    The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD).
  • Fda yellow dice
    Sep. 29, 2021
    By Mark McCarty

    FDA draft for investigator safety reporting offers little detail on combo product studies

    The FDA unveiled a draft guidance addressing the responsibilities of clinical investigators for safety reporting for investigational drugs and devices, a novel attempt to combine the disparate adverse event reporting timelines for investigational drugs and devices.
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Authors

  • Meg Bryant
  • Liz Hollis
  • Annette Boyle
  • Mark McCarty
  • Catherine Longworth
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